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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02770040




Registration number
NCT02770040
Ethics application status
Date submitted
9/05/2016
Date registered
12/05/2016
Date last updated
6/07/2016

Titles & IDs
Public title
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
Scientific title
PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial
Secondary ID [1] 0 0
HREC/14/Austin/595
Universal Trial Number (UTN)
Trial acronym
PREDICT-UC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Infliximab

Active Comparator: Intensified Infliximab Induction - Infliximab 10mg/kg at Week 0 and Week 1

Active Comparator: Accelerated Infliximab Induction - Infliximab 5mg/kg at Week 0, Week 1 and Week 3

Active Comparator: Standard Infliximab Induction - Infliximab 5mg/kg at Week 0, Week 2 and Week 6


Treatment: Drugs: Infliximab
INFLIXIMAB (REMICADE) in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution and infused

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Colectomy free survival
Timepoint [1] 0 0
Day 90
Primary outcome [2] 0 0
Clinical response - defined as a reduction in the Lichtiger score below 10 with a decrease of at least 3 points
Timepoint [2] 0 0
Day 14
Secondary outcome [1] 0 0
Treatment failure - Absence of clinical response at day 7
Relapse between day 7 and 90 (defined as a Lichtiger score increase of at least 3 points from the previous value that lasts for at least 3 consecutive days and leads to treatment modification)
A severe adverse event leading to treatment interruption
Colectomy by day 90
Death.
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Differences in daily Lichtiger score
Timepoint [2] 0 0
From day 0 to day 7
Secondary outcome [3] 0 0
Steroid free remission - defined as a Mayo disease activity index score =2 with an endoscopic subscore =1
Timepoint [3] 0 0
Day 90
Secondary outcome [4] 0 0
Endoscopic remission rate - defined as a Mayo endoscopic subscore of 0
Timepoint [4] 0 0
Day 90
Secondary outcome [5] 0 0
Endoscopic remission rate - defined as a Mayo endoscopic subscore of 0
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Colectomy free survival
Timepoint [6] 0 0
12 months

Eligibility
Key inclusion criteria
- Age >18 years old

- Diagnosis of Ulcerative Colitis

- Acute Severe Colitis according to the Truelove and Witt's Criteria

- Steroid refractory according to the Oxford Criteria
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant unable to consent for themselves

- Indication for immediate surgery (acute abdomen, perforation of the bowel,
haemorrhage)

- Crohn's disease

- Participants with enteric infection confirmed on stool microscopy, culture or toxin

- Haemodynamic instability (mean arterial pressure <60) and not responsive to fluids

- Participants with clinically significant Cytomegalovirus infection (positive inclusion
bodies, immunohistochemistry and signs of viraemia such as fever and abnormal liver
function tests)

- Participants who are pregnant or currently breast-feeding

- Participants with current malignancy, excluding basal cell carcinoma

- Participants with flat low or high grade colonic dysplasia; sporadic adenomas
permitted

- Participants with serious co-morbidities including: Immunodeficiency; Myocardial
infarction or acute stroke within the last 3 months; Moderate or severe heart failure
(New York Heart Association class III or IV); Active or suspected tuberculosis; Renal
failure; Hepatic failure; other severe infections

- Participants with history of hypersensitivity to infliximab or infliximab biosimilar

- Participants who have received other immunosuppressive agents including but not
limited to: Anti-TNF therapies within 3 months of screening (Infliximab, Infliximab
biosimilar, Golimumab, Etanercept, Certolizumab or Adalimumab); Anti-integrins
(Vedolizumb, Etrolizumab) within 4 months of screening; Calcineurin inhibitors
(Cyclosporine, Tacrolimus) within 4 weeks of screening; T or B cell depleters
(Rituximab, Alemtuzumab) within 12 months of screening; other investigational agents
(eg. Ustekinumab) within 6 months of screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to identify whether an Accelerated or Intensified Infliximab
induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an
open label multi-centre randomised controlled trial.
Trial website
https://clinicaltrials.gov/show/NCT02770040
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter De Cruz, MBBS PhD FRACP
Address 0 0
Austin Health, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter De Cruz, MBBS PhD FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 3 9496 6845
Fax 0 0
Email 0 0
Peter.DeCruz@austin.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02770040